New study tests Long-Term safety of Cholesterol-Lowering injection for kids

NCT ID NCT05682378

Recruiting now Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the long-term safety of inclisiran, a cholesterol-lowering injection, in children with a genetic condition that causes very high cholesterol. About 195 kids who completed earlier inclisiran studies will receive the drug for an extended period. Researchers will track side effects and how well the drug keeps cholesterol levels down.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

Inclisiran (a cholesterol-lowering injection)

What this could lead to

If successful, this could show that inclisiran is safe and effective for long-term use in children with inherited high cholesterol, helping control their condition.

What could go wrong

This is an extension study with no placebo group, so results may be less reliable. It only includes kids who already benefited, which may not represent all patients. Long-term side effects are still unknown.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HETEROZYGOUS OR HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

familial hypercholesterolemia homozygous familial hypercholesterolemia Hyperlipoproteinemia Type II

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HETEROZYGOUS OR HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA

Contacts and locations

Show contact details

Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••
Contact

Phone: •••-•••-••••

Locations

Childrens Hosp Pittsburgh UPMC
ACTIVE_NOT_RECRUITING

Pittsburgh, Pennsylvania, 15224, United States
Cincinnati Childrens Hospital MC
COMPLETED

Cincinnati, Ohio, 45229-3039, United States
Excel Medical Clinical Trials LLC
COMPLETED

Boca Raton, Florida, 33434, United States
Icahn School of Med at Mt Sinai
ACTIVE_NOT_RECRUITING

New York, New York, 10029, United States
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Formosa, Formosa Province, P3600, Argentina
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Fortaleza, Ceará, 60430-275, Brazil
Novartis Investigative Site
COMPLETED

São Paulo, São Paulo, 04023-900, Brazil
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

São Paulo, São Paulo, 05403 000, Brazil
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Québec, Quebec, G1V 4W2, Canada
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Prague, 128 08, Czechia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Prague, 150 06, Czechia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Besançon, 25030, France
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Toulouse, 31059, France
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Frankfurt am Main, Hesse, 60590, Germany
Novartis Investigative Site
COMPLETED

Freiburg im Breisgau, 79100, Germany
Novartis Investigative Site
COMPLETED

Athens, 115 27, Greece
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Athens, 185 47, Greece
Novartis Investigative Site
COMPLETED

Pécs, Baranya, 7623, Hungary
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Jerusalem, 9112001, Israel
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Ramat Gan, 5265601, Israel
Novartis Investigative Site
COMPLETED

Milan, MI, 20162, Italy
Novartis Investigative Site
COMPLETED

Modena, MO, 41124, Italy
Novartis Investigative Site
COMPLETED

Roma, RM, 00161, Italy
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Roma, RM, 00165, Italy
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Irbid, 22110, Jordan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Beirut, 113-0236, Lebanon
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Beirut, 166830, Lebanon
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Sungai Buloh, Selangor, 47000, Malaysia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Kuala Lumpur, 59100, Malaysia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Amsterdam, North Holland, 1105 AZ, Netherlands
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Rotterdam, South Holland, 3015 GD, Netherlands
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Oslo, 0514, Norway
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Gdansk, 80 952, Poland
Novartis Investigative Site
COMPLETED

Lodz, Łódź Voivodeship, 93-338, Poland
Novartis Investigative Site
COMPLETED

Kemerovo, 650002, Russia
Novartis Investigative Site
COMPLETED

Moscow, 127412, Russia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Poprad, 058 01, Slovakia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Ljubljana, 1000, Slovenia
Novartis Investigative Site
COMPLETED

Bloemfontein, Free State, 9301, South Africa
Novartis Investigative Site
COMPLETED

Cape Town, Western Cape, 7130, South Africa
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Pamplona, Navarre, 31008, Spain
Novartis Investigative Site
COMPLETED

Oviedo, Principality of Asturias, 33011, Spain
Novartis Investigative Site
COMPLETED

A Coruña, 15001, Spain
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Córdoba, 14004, Spain
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Geneva, 1211, Switzerland
Novartis Investigative Site
RECRUITING

Taipei, 111045, Taiwan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Istanbul, Fatih, 34098, Turkey (Türkiye)
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Adana, Saricam, 01330, Turkey (Türkiye)
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Ankara, Yenimahalle, 06500, Turkey (Türkiye)
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Izmir, 35100, Turkey (Türkiye)
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Middlesex, UB9 6JH, United Kingdom
Primary Childrens Medical Center
COMPLETED

Salt Lake City, Utah, 84113, United States